Amedica submitted its responses to the FDA's questions regarding its CASCADE clinical trial.
Here are four notes:
1. The clinical trial compared the 24-month outcomes of Amedica's porous silicon nitride product versus bone autograft for single-level cervical fusion.
2. The trial's results showed the two had comparable outcomes.
3. The FDA will make its final decision regarding the product's clearance in 60 days.
4. Once approved, Amedica will begin manufacturing and selling the CASCADE product.